None listed
Conditions
Interventions
Others(Health Functional Food) : The test food of this human trial consists of CC (Cockscomb Extract) and a Placebo, and the test food contains 240mg of CC (Cockscomb Extract) per 450mg of 1 capsule,
Sponsors
Kangbuk Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Those who are 19 years of age or older and 65 years old or younger 2) Those with a Body Mass Index(BMI) are more than 25 kg/m²and less than 30 kg/m² 3) A person who agreed to participate in this Clinical Study and filled out an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Those who is currently being treated for severe diseases such as cardiovascular, immune, respiratory, gastrointestinal/hepatic and biliary tract, kidney and urinary system, nervous system, psychotropic, infectious diseases and malignant tumors(However, in consideration of the condition of the clinical trial subject, it is possible to participate in the test according to the judgment of the investigator). 2) Drugs that affect weight within 1 month (30 days) of visit 1 {obesity drugs (appetite suppressants, fat absorption inhibitors, GLP-1 receptor agonists, etc.), psychiatric drugs such as depression and schizophrenia, beta blockers, Diuretics, contraceptives, steroids, female hormones, thyroid hormones}, hyperlipidemia drugs (including omega 3), health functional foods/supplements for weight control, herbal medicines and formula foods for weight control, health functional foods for improving blood lipid and cholesterol(oils and fats containing EPA and DHA, indigestible maltodextrin, and gamma-linolenic acid, lecithin, phytosterols, etc.). 3) Those who have undergone obesity surgery within 1 year of visit 1 4) Patients with uncontrolled hypertension(systolic blood pressure 160 mmHg or more, diastolic blood pressure 100 mmHg or more, measured after 10 minutes of rest in clinical trial subjects) 5) Diabetic patients with fasting blood glucose of 126 mg/dL or more or taking anti-diabetic drugs (oral hypoglycemic agents, insulin, etc.) 6) Those whose TSH is less than 0.1 µIU/mL or more than 10 µIU/mL 7) Those whose creatinine is more than twice the upper limit of the normal limit of the implementing institution 8) Those whose AST (GOT) or ALT (GPT) is more than 3 times the upper limit of the implementing institution 9) Those with alcohol use-induced?disorder or central nervous system disorder 10) Those who are judged to be unable to exercise due to musculoskeletal disorders 11) Those who have had a weight change of 10% or more within 3 months based on visit 1 12) Those who have participated in a commercial obesity program within 3 months of visit 1 13) Those who have participated in other interventional clinical trials (including human trials) within 3 months of visit 1, or who plan to participate in other interventional clinical trials (including human trials) after the start of this human trial 14) Those who are pregnant, lactating, or planning to become pregnant during this human trial 15) Those who have problems with the intake of food for human trials due to severe gastrointestinal disorders 16) Those who are sensitive or allergic to the ingredients of this test in this human trial 17) Those who are judged unsuitable by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in fat free mass(g) and fat percentage(%) by Dual Energy X-Ray Absorptiometry, DEXA | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in body weight and Body Mass Index(BMI);Changes in thigh, arm, waist, hip, and waist/hip circumference ratios;Changes in lean body mass(g) by Dual Energy X-Ray Absorptiometry, DEXA;Changes in mesenteric fat area, subcutaneous fat area, total abdominal fat area, mesenteric/subcutaneous fat area ratio by CT;Changes in blood lipid(Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride);Changes in hs-CRP, Adiponectin, Basal metabolic rate;Adverse Event, Hematology/Hematochemistry tests, Urine tests, Vital signs(blood pressure, pulse) | — |
Countries
Korea, Republic of
Contacts
Public ContactJAEHEON KANG
Kangbuk Samsung Medical Center
Outcome results
None listed